Method for aligning an acetabular cup

ABSTRACT

A method is used for aligning an acetabular cup insertion instrument by taking a single lateral view pre-operative digital x-ray of a standing patient&#39;s pelvis. The natural pelvic tilt angle is determined by locating an anterior pelvic plane (APP) which is defined by first, second and third points on the anterior of the pelvis and determining the angle between the APP and a coronal plane perpendicular to the surface on which the patient is standing. The patient is then placed on a surface of an operating room table in a supine position. A position tracking device is placed on the patient&#39;s pelvis to track movement. Thereafter an operating room navigation or orientation system is used to relocate the APP defined by the first, second and third points. A cup insertion instrument having a position tracking device thereon is oriented using the navigation or orientation system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/459,642, filed Aug. 14, 2014 which is a continuation-in-part of U.S.patent application Ser. No. 14/038,033, filed Sep. 26, 2013, now U.S.Pat. No. 9,248,002, issued on Feb. 2, 2016, the disclosures of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

Hip surgery requires the implantation of a femoral stem and anacetabular cup. The femoral stem has a spherical head that attaches tothe neck of the stem and is free to articulate within a bearing insertthat is fitted into the shell of an acetabular cup. Should the stem andcup not be positioned/aligned accurately, the neck of the stem mayimpinge on the lip of the insert resulting in a levering action thatcould allow the femoral head to cam out of the insert resulting in apermanent dislocation of the head. The impingement can also lead toexcessive component wear and possibly failure.

In addition, a malpositioned cup can result in excessive liner wear evenwithout impingement. A shell with a high abduction (inclination) anglecan have joint forces concentrated near the cup liner rim, therebyincreasing the wear rate due to concentrated forces.

Reducing or eliminating the chance for neck/insert impingement and highinclination angles is critical to eliminating dislocation and wear,which can ultimately result in a revision surgery to correct compoundalignment (abduction and anteversion).

A recent study by H. Malchau et al., Clin. Orthop. Relat. Res. (2011)469; 319-329 reviewed the implanted acetabular cup position postimplantation in relation to the pelvic anatomy. The study of 1823patients revealed that the cup position varied widely in reference totheir described target zone.

One main reason for such variation is that the exact position of thepatient's pelvis is not known in relation to the operating room (OR)table. Surgeons must rely on their experience to know how to positionthe cup, however the cup may not be implanted in the intendedorientation. This is especially true with respect to less experiencedsurgeons.

Alignment of an acetabular cup can be achieved with an alignment guidethat attaches to an insertion rod for facilitating the insertion of theacetabular cup into the acetabulum. The alignment guide preferablyreferences the surgical table on which the patient rests.Conventionally, it is assumed that the patient's pelvis is parallel tothe table, and that the surgical table is parallel to the floor. Basedon such assumptions, the ordinary position (in most patients) for theacetabular cup is 45° of inclination (abduction) and 20° of anteversion.For a discussion of angles of anteversion and also inclination orabduction of the acetabular cup when installed in the acetabulum, see,for example, “The Definition and Measurement of Acetabular Orientation”,The Journal of Bone and Joint Surgery, 75-B; pp. 228-32, (1993).

It has been found based on post-operative x-rays, however, that despitethe alignment guide being parallel to the floor during insertion, of theacetabular cup, the resultant inclination or anteversion of theacetabulum in relation to the alignment guide is often different thanexpected and, thus, the acetabular cup has been installed at a less thanideal position. The pelvic position changes in relation to the operatingroom table which is not recognized during the procedure for example.

Presently most orthopedic companies offer instrumentation to directreaming for acetabular cups and cup impaction which is an antenna-likedevice that attaches to either the reamer shaft or the cup impactiontool. Such cup alignment instruments are shown in, for example, U.S.Pat. Nos. 5,037,424, 5,571,111 and 6,395,005. When an x-shaped “antenna”is used a cup impactor that is oriented 45 degrees to the floor and 20degrees to the long axis of the patient. The ‘X’ shape on the antenna isset parallel to the floor, and one leg of the ‘X’ set in line with thelong axis of the body. One leg is for a left leg operation, and theother for a right leg operation.

Some of the drawbacks of this type of instrument are that the pelvisusually shifts when the patient is laid on the operating room table. Ifthe pelvis does not shift, and the surgeon wants a 45/20 cup position,then the surgeon could use the instrument as is and get the perfect45/20 alignment within the bone. However, most times the pelvis doesshift in three possible planes: tilt, obliquity, and rotation. Thesurgeon does not know in which direction or by how much and thereforemust use his experience or intuition to apply a correction factor to thedirection of cup impaction. The actual cup orientation after impactionis not usually known until after the operation is complete and apost-operative x-ray is taken, and the patient is in recovery, andtherefore at a time when changes to cup orientation are not possiblewithout reoperation.

Another drawback is that the current antenna/impactor combination is setat set angles. For example a 45/20 degree abduction/anteversionorientation. If the surgeon determines that orientation of 40° to thefloor and 15° to the long axis of the patient's femur is best for thepatient, the set angles are of little use, or again the surgeon has toestimate a correct alignment. The orientation of the antenna/impactorcombination in practice is set visually. The antenna shaft is setvertically, with the antenna ‘X’ cross bars parallel to the floor. The20 degree orientation to the patient long axis is visual as well. Manysurgeons do not use the antenna at all.

Some major prosthetic hip joint companies offer a navigation option tosurgeons. This system uses cameras in the operating room and opticaltrackers on instrumentation. From a clinical perspective, the majordrawbacks for navigation are that the technique involves placinginvasive pins having the tracker thereon in the patient pelvis andfemur. The pins are placed in the pelvis and the femur, through the skinand screwed into the bone. Using pins results in multiple separatewounds and increases the possibility of infection. This technique isalso time intensive. Pins must be placed and pointers with trackers onthem are used multiple times to register anatomy. This technique has alearning curve. The software and technique require extensive trainingand practical experience. Some systems require a pre-op CT scan which iscostly.

A more recent development is digital imaging which produces an x-raylike image on a digital receiver. Once digitized, the digital image canbe used to identify points in order for the system to calculate lengthsand angles which could be used by the surgeon to help to identify howthe pelvis is oriented to the operating room table. The surgeon can takepre-operative and intra-operative x-rays and pick points on the screento calculate lengths and angles. This is a relatively new technologywith a relatively small amount of users.

The x-rays can be visually observed for comparison. The system can aidthe user by allowing the user to plan by designating the desired cupinclination and version angles pre-operatively as well as takingdimensions that will help to designate leg length and femoral stemoffset corrections. Taking dimensions that will measure the cupinclination and version angles of the actual implanted cupintra-operatively as well as taking dimensions that show that actual leglength and offset of the trials or implants.

However, they do not aid the user by figuring out how the pelvis hasshifted on the table as there is no algorithm to do this. A pelvis mayhave tilted by 15 degrees, yet the cup angle measurement only measuresthe cup angle at the plane that the x-ray is taken. If the pelvis hastilted by 15 degrees, then the correct cup placement would not be45°/20° to the intra-op x-ray image, but should be adjusted to accountfor the tilt.

These current digital imaging systems do not have an algorithm thattries to compare pre-operative and intra-operative images to calculatehow the intra-operative pelvic position changes in orientation to apre-operative image. Furthermore, the current digital systems don'tcalculate the cup impaction angles that would account for these changes.Instead the cup needs to be first impacted into the bone prior to takingthe image, and reoriented if not in the desired position. Reorientingthe shell could compromise the fit and security of the cup to theacetabular bone cavity. Multiple reorientations could possiblycompromise the fit to the point that a secure fit is no longer achieved.In this situation, the surgeon may have to remove the shell, ream up tothe next size shell, and start over. The removal of further acetabularbone is not ideal as this could compromise the overall strength of theremaining bone, and reduce the amount of bone for any future revisions.Current digital imaging techniques require successive intra-operativeimages, exposing the patient and the surgical team to higher levels ofradiation than with a single image.

BRIEF SUMMARY OF THE INVENTION

The present invention uses a pre-operative lateral x-ray image todetermine the pelvic tilt angle that is natural for each patient. In thepreferred embodiment, the pre-operative lateral x-ray is taken while thepatient is standing. The invention describes using a pre-operativelateral x-ray image in conjunction with an intra-operative orientationtechnology. The pre-operative pelvic tilt angle is used in conjunctionwith the orientation technology to determine how the pelvis may haveshifted during surgery and allow the surgeon to adjust accordingly andimplant the cup at the pre-determined orientation. Below summarizes twoembodiments, one preferred embodiment for the patient in the lateraldecubitus position (laying on their side), and the other for the patientin the supine position.

In the first embodiment of the present invention, the patient is in thelateral decubitus position for the surgery, uses a combination ofdigital imaging and orientation technology to improve upon thelimitations described above, along with an algorithm that determines theamount of pelvic movement in the three planes (obliquity, tilt,rotation) that is used as input for the orientation technology. Thepreferred embodiment to calculate pelvic tilt obliquity and rotationinoperatively which no other system does. Most pre-operative x-rayimages are taken laying down (supine), and hence placing the pelvis inan unnatural position. A standing x-ray is the gold standard as theamount of pelvic tilt when standing is what is right for thatindividual. This invention serves to recreate the natural standing x-raytilt and, if desired, obliquity and rotation amount intra-operatively byadjusting the orientation of reaming and cup impaction, and performingthese functions at the pre-op plan angles determined by the user (e.g.at 40° inclination and 15° anteversion).

The invention uses a method for aligning an acetabular cup including:taking a pre-operative preferably standing anterior/posterior viewdigital x-ray image and a lateral view standing digital x-ray image ofthe pelvis of a patient. A desired cup abduction and anteversion angleis determined based on two standing x-ray images. At least three pointson the digital anterior/posterior digital x-ray image and at least twopoints on the lateral digital x-ray image are identified. The lengthsand angles between each of the points on both the anterior/posteriordigital image and the lateral digital image are calculated. A patient ispositioned on an operating table in an operating room. The preferredoperating table has a reference element thereon. In the preferredembodiment, the operating room has a navigation system (orientationtechnology) therein, the preferred operating table has a navigationtracker mounted in a known position with respect to the operating table.Alternately, the reference system could reference the floor or otherfixed point including the operating room table. At least one pelvicdigital x-ray image of the patient positioned on the operating table istaken with the x-rays including the reference element. At least threepoints are identified on the intra-operative x-ray image. In thepreferred embodiment, the points corresponding to the points on thepre-operative x-ray image. The lengths and angles between each of the atleast three points on the intra-operative digital images are thencalculated. An intra-operative angular deviation of the acetabular cupinsertion instrument from the desired abduction and anteversion anglei.e. calculated by comparing the dimensional differences between thepoints on the pre-operative standing x-ray images and the at least oneintra-operative x-ray image. The insertion instrument is then aligned toa calculated angular position, based on the intra-operative deviation,using the navigation camera and a navigation tracker mounted on theinsertion instrument.

The at least three points on the anterior/posterior pre-operative andintra-operative images are preferably the right and left promontorypoints and the pubic symphysis. The at least two points on theintra-operative lateral image are preferably the left or rightpromontory and the public symphysis. However, other points can be used.Additional points may be selected from the group consisting ofacetabular teardrops, the obturator foramen and the base of the left andright ischial rings, the points being identified on the pre-operativeand intra-operative images. The angle between a line connecting theischial ring points and the reference element indicates any obliquelychange between the pre-operative, preferably standing pelvicanterior/posterior x-ray image and the at least one intra-operativex-rays. The reference element may be a radiopague or radiolucent barextending parallel to the operating table surface, the radiolucent barhaving two radiopaque markers thereon. Alternately, the radiolucent barhas three radiopaque markers, each marker located at an apex of atriangle. The radiopague bar could be made of metal preferably with athin cross-section in the direction of the x-ray beam. The bar could bemetal or aluminum which is semi-transparent to an x-ray beam. Thepre-operative determination of the desired cup abduction and anteversionangles based on the standing x-ray are about 30 to 50 degrees and 10 to30 degrees respectively. The calculations are performed by a computerusing digital image analysis software receiving input from a digitalx-ray machine and an operating room navigation tracking system. Pelvictilt may be calculated by comparing the distance between the promontorypoints and the pubic symphysis on both the pre-operative standing x-raysand the at least one intra-operative x-ray.

As used herein when referring to bones or other parts of the body, theterm “proximal” means close to the heart and the term “distal” meansmore distant from the heart. The term “inferior” means toward the feetand the term “superior” means toward the head. The term “anterior” meanstoward the front part or the face and the term “posterior” means towardthe back of the body. The term “medial” means toward the midline of thebody and the term “lateral” means away from the midline of the body. Thesagittal plane, being a plane parallel to the sagittal suture, dividesthe body into left and right portions. The median plane is in themidline; i.e. it would pass through midline structures such as the navelor spine, and all other sagittal planes are parallel to it. The coronalor frontal plane divides the body into dorsal and ventral (back andfront, or posterior and anterior) portions. The transverse plane, alsoknown as an axial plane or cross-section, divides the body into cranialand caudal (head and tail) portions.

The second embodiment of the present invention whereas the patient is inthe supine position, uses a combination of a pre-operative lateral x-rayimage and orientation technology to improve upon the limitationsdescribed above.

The various aspects of the present invention are accomplished by amethod for aligning an acetabular cup insertion instrument using only asingle digital x-ray. A single lateral view pre-operative digital x-rayof standing patient's pelvis is taken and the natural pelvic tilt angleis determined by locating an anterior pelvic plane (APP) defined byfirst, second and third points on the anterior of the pelvis.Alternatively, two points could be taken on the lateral x-ray if theleft and right ASIS points are aligned. In this case, a single pointdefines both the left and right ASIS. The other point being the publicsymphysis. The angle between the APP and a coronal plane perpendicularto the surface on which the patient is standing is then determined. Thepatient is then placed on a surface of an operating room table in asupine position. A position tracking device is placed on the patient'spelvis to track movement of the pelvis during surgery. Thereafterrelocating the APP defined by the first, second and third points isagain located. Thereafter the coronal plane is located by using thedetermined natural pelvic tilt angle and APP plane, an acetabular cupinsertion instrument having a position tracking device thereon isoriented at a predetermined abduction angle with respect to the sagittalplane, and anteversion angle with respect to the coronal plane.

The first, second and third points may be the pubic symphysis, the leftanterior superior iliac spine and the right anterior superior iliacspine.

A position tracking device may be used to intraoperatively locate thepubic symphysis and the left and right anterior superior iliac spines.

A sagittal plane is defined through a mid-point between the left andright anterior superior iliac spines and perpendicular to the coronalplane.

A cup insertion instrument is then oriented at a predetermined abductionangle with respect to the sagittal plane and a predetermined versionangle with respect to the coronal plane.

The predetermined desired cup abduction and anteversion angles are about30 to 50 degrees and preferably between 10 to 30 degrees respectively.

The orientation of the cup insertion instruments is directed by acomputer using digital image analysis software receiving input from thesingle digital x-ray and the operating room position tracking system.Note that the lateral image pelvic tilt angle can be determined from astandard non-digital x-ray and angle value then used in thecalculations.

Further aspects of the invention are achieved by a method for aligningan acetabular cup insertion instrument using only a single digitalx-ray. The single x-ray is a single standing lateral view pre-operativedigital x-ray of a standing patient's pelvis. The patient's naturalpelvic tilt angle may be determined by locating an anterior pelvic plane(APP) defined by points at the pubic symphysis, the left anteriorsuperior iliac spine and the right anterior superior iliac spine. Theangle between the APP and a coronal plane is then determined. Thepatient is then placed on a surface of an operating room table in asupine position. Thereafter, using an operating room navigation systemposition tracking device the pubic symphysis, the left anterior superioriliac sine and the right anterior superior iliac sine points arelocated.

The predetermined angles are an abduction angle and an anteversion angleand the predetermined desired cup abduction and anteversion angles arepreferably about 30 to 50 degrees and 10 to 30 degrees respectively.

Once the anteversion and abduction angles are known, the orientation ofthe cup insertion instruments may be directed by a computer usingdigital image analysis software receiving input from the single digitalx-ray and the operating room position tracking system.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B and 1C are reference diagrams showing pelvic obliquity,pelvic rotation and pelvic tilt which three axial movements typicallyoccur when moving from a standing position to a prone position;

FIG. 2 shows nine possible anatomic landmarks on a pelvicanterior/posterior x-ray;

FIG. 3 shows three points on a pelvic anterior/posterior x-ray includingthe right and left promontory points and the pubic symphysis;

FIG. 3A shows a lateral view of a lateral x-ray showing a leftpromontory point located directly above the right promontory point andthe pubic symphysis;

FIG. 4 shows an artist's rendition of an anterior/posterior standingx-ray showing the three points of FIG. 3 and dimensions A, B and C;

FIG. 5 shows an artist's rendition of a lateral x-ray showing theanatomic points shown in FIG. 3A including the dimensions D, E and Ftherebetween;

FIG. 6 shows a reference system mounted on an operating table includinga radiolucent reference element and two radiopaque markers;

FIG. 7 shows a pelvis area of a patient located on an operating tableshowing the right and left promontory points, pubic symphysis and thebase points of the right and left ischial rings;

FIG. 8 is an anterior/posterior x-ray showing the anatomic landmarkpoints on the pelvis;

FIG. 8A is an artist's rendition of a pelvis of a patient oriented on anoperating table having a reference element mounted thereon with thepelvis in a first orientation having a pelvic tilt;

FIG. 8B is an artist's rendition of the pelvis of 8A showing the variouscomponents for a reaming operation including the chosen landmarks.

FIG. 8C is a lateral x-ray of the patient's pelvis of FIGS. 8 to 8B;

FIG. 8D is a picture of the anterior pelvic x-ray showing the guide barand the promontory points and the symphysis;

FIG. 8E shows three views of a pelvis, in an idealized position on anoperating table on three standing image planes with an acetabularimpactor at 45% version.

FIGS. 9 and 9A are an artist's idealized rendition of an intra-operativex-ray image taken in the anterior/posterior and lateral views of apelvis on an operating table in a second position;

FIG. 10 shows an example of pelvis shift in the standing plan x-ray whena patient is placed on an operating table.

FIGS. 10A and 10B are anterior and posterior intra-operative views of apelvis on an operating table showing 45° inclination and 20°anteversion;

FIGS. 11, 11A, 11B, 11C, and 11D show the reorientation of theacetabular cup impactor/reamer from a pre-operative plan based on astanding x-ray to an intra-operative plan accounting for movement of thepelvis with 10° tilt;

FIG. 11B shows the lateral view of FIG. 11 and FIG. 11A shows the pelviswhen there is a 10° tilt;

FIGS. 12, 12A, 12B, 12C, 12D, 12E, 12F, 12G, 12H, 12I, 12J, 12K and 12Lshow the repositioning of an acetabular cup impactor/reamer from aninter-operative plan of 45° inclination and 20° anteversion with 8°rotation of the pelvis when placed on an operating table as set forth inexample 4 of the present application;

FIGS. 13, 13A, 13B, 13C, 13D, 13E, 13F and 13G show the repositioning ofan acetabular cup impactor or reamer from a pre-operative plan based ona standing x-ray with 45° inclination and 20° anteversion desired basedon the standing x-ray with the pelvis being rotated in 10° of obliquityas set forth in example 5 of the present application;

FIGS. 14, 14A, 14B, 14C, 14D and 14E show the repositioning of anacetabular cup impactor/reamer where the desired orientation is 45°inclination and 20° anteversion based on a standing x-ray with 10° ofobliquity imparted to the pelvis when being placed on an operating tableas set forth in example 6 of the present application;

FIGS. 15, 15A, 15B, 15C and 15D of the present application show therepositioning of an acetabular cup impactor from a desired 45°inclination and 20° anteversion based on a standing x-ray to a pelvisoriented on an operating table with 10° tilt, 8° rotation and 10°obliquity change from the standing x-ray as set forth in example 7, withFIGS. 15 and 15A showing the standing x-ray anterior/posterior plane,the central plane and a rotational plane of the pelvis along with the x,y and z vectors laying on each of the planes;

FIG. 16 shows a preoperative image showing an individual with one legshorter than the other (non-zero pelvic tilt in the x-ray); and

FIG. 17 is a preoperative standing lateral x-ray image showing thecoronal plane and the anterior pelvic plane;

FIG. 18 is a schematic view showing an operating table with a pelvispositioned thereon in a supine position including the coronal plane,anterior pelvic plane, and sagittal plane;

FIG. 19 shows a navigation system tracker mounted on the pelvis of thepatient while laying on the operating table in the supine position;

FIG. 20 schematically shows an image of a pelvis located in the supineposition on an operating table with three points defining the anteriorpelvic plane, the three points being the left anterior superior iliacspine, the right anterior superior iliac spine and the pubic symphysis;

FIG. 21 is a schematic view showing the pelvis located on an operatingtable in a supine position showing in the navigation system tracker, thecoronal plane and the anterior pelvic plane;

FIG. 22 is a schematic view similar to FIG. 21 also showing a sagittalplane extending perpendicularly to the coronal plane through themidpoint between the anterior superior iliac spines;

FIG. 23 is a schematic top view of an operating table with the pelvispositioned in the supine position showing an acetabular alignmentinstrument located at an abduction angle in the coronal plane;

FIG. 24 shows a schematic side view of a pelvis positioned on theoperating table in the supine position with a version angle shown for anacetabular cup alignment instrument with 20° of version; and

FIG. 25 is a schematic view of a typical operating room navigation ororientation system for use with the method for aligning the acetabularcup described herein.

DETAILED DESCRIPTION

The method for aligning an insertion instrument for an acetabular cup ofthe present invention will now be described. It is shown in thepreferable embodiment of the lateral decubitus position, however,similar method could be used for the supine position. Such an insertioninstrument may be a reamer or impactor. For definitional purposes,pelvic obliquity and tilt rotation are shown respectively in FIGS. 1A,1B and 1C. Initially a pre-operative digital standing A/P(anterior/posterior)(FIGS. 2 and 3) and lateral view x-ray (FIG. 3A)images of a pelvis 10 are taken. A magnification marker (not shown) maybe included in these two x-rays.

The goal of the invention is that a pre-operative x-rays (FIGS. 3 and3A) are taken and a plan established for the best acetabular cupposition (inclination and version) relative to right and left acetabulumpelvis 10 for the individual patient. The pre-operative A/P plane isreestablished the calculations relative to the intra-op pelvis position(FIG. 3).

The pre-operative cup position plan for inclination and version is thenapplied to the reestablished plane. In order to do this, at least someof the changes that took place in tilt, obliquity and rotation fromtheir pre-operative position (angular changes) are determined and thenused with the acetabular cup impactor. This can be done without placingany additional pins or other elements in contact with the body so othertrackers can be attached to the pelvis.

In the preferred embodiment, the x-ray images are taken with the patientstanding. A standing image naturally orients the pelvis to theindividual patients natural pelvic tilt, obliquity and rotation.

Referring to FIG. 2 to FIG. 5, the surgeon identifies at least five ormore specific points on the images (three on A/P x-ray and two onlateral x-ray). The three points on the A/P x-ray are preferably theleft and right promontory 20, 22 and pubic symphysis 24. The two pointson the lateral x-ray are the lateral promontory point 22 and the pubicsymphysis 24. Other possible pelvic anatomy points are shown in FIG. 2as the bases of the left and right ischial rings 30, 32, the left andright inside obturator foramen 34, 36 and the left and right acetabularteardrops 37 and 39. It may not be necessary to compare every pre andintra-operative dimension to calculate tilt, rotation and obliquitychanges.

Computer software may be used to calculate lengths and angles betweenthese five points and retains the calculated dimensions to compare to afuture correlated intra-operative dimension on intra-operative x-rays.For example, FIG. 4 shows lengths A, B C and D based on points 20, 22and 24 and FIG. 5 shows lengths D, E and F based on points 22 and 24 anda point 25 at the origin of a right triangle formed by points 22, 24.

Referring to FIGS. 6 and 7, the intra-operative routine starts with thepatient being placed on an operating table 46 usually on the sideopposite the hip being replaced. The surgeon performs the operation upto the point of reaming the acetabulum for acetabular cup. Prior totaking an intra-operative image, a reference plane is established. Thereference plane is used to translate the angular changes to angulardimensions for a single measurement orientation system, such as anavigation system, to use to direct the reamer and acetabular cupplacement. On orientation system is any system that can be used to trackmovements for a computer locating system. A camera tracking systemincluding trackers mounted on the body as shown in FIG. 25. Alternatelyweb cameras can be attached to the pelvis and track landmarks in theoperating room. Referring to FIGS. 6 and 7, preferably a radiolucentreference system 38 generally denotes as (system 38) with two or threesystem 38 ¹ of FIG. 7, radiopaque markers 44, 45 and 47, is attached tothe table. Reference system 38, 38 ¹ needs to be located so it is ableto be included in the intra-operative x-ray image. Reference system 38,38 ¹ have a horizontal bar 40 which and can be mounted on a post 42vertically mounted on operating table. The reference element could alsobe just the post with radiopaque markers, and the post could be apatient positioning post for a peg board. The reference systems 38, 38 ¹could conceivably be the actual operating room table 46. Preferably, anavigation system tracker 50 is then placed on the reference bar 40.Magnification markers could be included in or on reference bar 40. Bar40 could be made out of radiolucent material with at least onemagnification marker imbedded in the bar. The markers could be sphericalin shape and the points taken could be the centers of the markers. Thebar could also be make out of a semi-radiolucent material such asaluminum as shown in 8D whereas the edge of the bar itself wouldsubstitute or having radiolucent markers.

As shown in FIGS. 8A to 8E, at least one intra-operative digital x-rayimage (preferably an A/P image FIG. 8) is taken making sure thereference bar 40 is within the image (see FIGS. 8A to 8E). The surgeonidentifies at least 5 specific points on the intraoperative A/P image.The preferred embodiment has the surgeon identifying seven points. Thepromontory points 20, 22 and pubic symphysis point 24 are similar to thepre-operative image. The two ischial ring points 30, 32 are used todetect obliquity change. (Note: Other points that are meant besymmetrical about the pelvic anatomy can be chosen. Examples are: insideleft and right obturator foramen 34, 36, and left and right acetabularteardrops 37, 39. The two ischial points or other symmetrical points arechosen to make calculating the obliquity easier. The line between thetwo promontory points could also be used, negating the need for twoother symmetrical points), and two points on the reference element 40are used to detect the orientation of the bar to the other points.

Software is used to calculate key lengths and angles between points onintraoperative image. Note that the specific points are at the center ofthe pubic symphysis 24, the two promontory points 20, 22, a point 37 atthe center between the promontory points, and a point 49 that is 90° tothe line between the promontory points. By determining the angularchanges in tilt obliquity and rotation of the pelvis, the software canrecreate a virtual standing image in reference to the pelvic position onthe table (FIG. 8E).

The software identifies abduction and anteversion angles relative to thereference in order to achieve the pre-operative desired cup position asshown in FIGS. 3 and 4. Referring to FIGS. 5, 6, 7, 8 and 9, thepreferred embodiment uses commercially available navigation system isused to determine the position of the cup impaction angle versus thereference bar 40. A tracker 50 is placed on bar 40 and a tracker 52 isplaced on a cup impactor 54. Impactor 54 includes shaft 56 extendingalong axis 59 which engages the inside of an acetabular cup shell orreamer 5 located in acetabulum 11, 13. The impactor is adjusted to theangles α and β calculated by a computer program while looking at amonitor. Preferably, the same monitor as the digital image monitor.Alternate embodiments could obtain the desired angles via manualgoniometers or protractors, or via electronic means such as with aninclinometer. Software for the required calculation is commerciallyavailable.

The surgeon then reams the acetabulum at indicated calculated angleswith a standard acetabular reamer. If the surgeon suspects that thepelvis has moved prior to cup impaction, then an x-ray of the at leastfive points can be retaken. The surgeon impacts cup at the calculatedangles α and β.

The following examples show calculations and workflow of variouspossible intraoperative pelvic orientations.

Example 1

This example shows how the cup impactor is positioned relative toreference bar 40 to obtain the desired inclination and anteversion. Thepelvis is shown in a perfect orientation similar to FIG. 8D.

Referring to FIGS. 9 and 9A there is shown a “perfect” pelvicorientation on table 46. Also shown is the acetabular cup impactor 54with shaft 56 shown at a 45° inclination 0° anteversion and zero tilt,rotation and obliquity with respect to reamer or impactor 57.

As shown in FIGS. 9 and 9A pelvis 10 did not alter position from the A/Pimage (pelvis in a perfect position) when placed on table 46. The basicpelvis orientation is exactly 90° to the standing x-ray. The plane isnormal to the table. This is shown by the 0° alignment between theplanes of the two x-rays (pre-standing and intraoperative prone). Theplane that the standing x-ray was taken at is shown with the line 59 ofFIG. 9. The plane through line 59 is normal to the table. The impactoris placed in the reamed acetabulum and rotated up to 45° in relation tothe reference bar 40. In general, the plane that the standing x-ray wastaken at is first found, and then impactor 54 is angled for inclinationalong that plane, and then anteversion is placed normal to the plane bypivoting in the acetabulum (in example 1 this is 0°). The bar 40 definesthe plane normal to the intra-operative x-ray view and parallel to thefront edge of the table. It is perpendicular to the cross-table x-rayimage taken in the operating room. The front edge of the operating roomtable could also be used as a reference, however, the size of the x-rayimage may not be able to capture both the table and the anatomy requiredin the same shot. Having a reference bar 40 attached to the table allowsit to be moved to a position that is within the image and not blockingthe anatomic points needed for the calculations. The navigation tracker50 is attached to whatever the reference is, whether it be the bar orthe table itself.

Referring to FIG. 10, the navigation system first recreates the standingx-ray plane 37, defines a central plane 39 then calculates the amountthe pelvis has moved off that reference plane. A rotational plane 35 isalso shown. Reference bar 40 defines plane normal to x-ray view andparallel to table.

Example 2

Referring to FIGS. 10A and 10B, similar “perfect” pelvic orientation onthe OR table as with Example 1. Standing x-ray plane is normal to thetable shown with acetabular cup impactor at a now desired 45°inclination (FIG. 10A) and 20° anteversion (FIG. 10B). The cup impactor54 would be oriented 45° from the reference bar 40 and 20° off thereference bar 40. The two navigation trackers 50, 52, one of thereference bar, and one on the impactor helps facilitate finding theseangles for the impactor. The orientation is now 45 DEG INCLINATION, 20ANTEVERSION, 0 TILT, 0 ROTATION and 0 OBLIQUITY.

Example 3

Here the cup impactor orientation is 45° INCLINATION, 20° ANTEVERSION,AND THE PELVIC ORIENTATION IS 10° TILT (to be confirmed below), 0°ROTATION and 0° OBLIQUITY. Dimensions for calculations for determiningamount of tilt are pre-op images are shown in FIGS. 11, 11A and 11B.Intra-op image: A/P image shown in FIG. 11A: May have tilt. This is tobe verified by the calculation outlined below. A Pre-op A/P, preferablystanding image is taken and shown in FIG. 11. An Intra-operative A/Pimage is taken and shown in FIG. 11A. The 3.179 dimension between points24 and 35 is compared to the pre-op dimension of 2.599 between points 24and 49. Since the 3.179 is greater than 2.599, it indicates that thepelvis has tilted forward (positive tilt) by a certain amount.Dimensions for calculations for determining amount of tilt: Apre-operative lateral image is shown in FIG. 11B with lengths B, C, andE and angle D.

Table 1 refers to the dimensions of FIGS. 11A and 11B.

TABLE 1 Name Feature length/ Letter Given angle Pre-op Intra-op APromontory Between Promontory 4.173 4.173 Line points B Normal On A/PImage: (90 2.599 3.179 Line deg) between Prom Line and Pub Sym. OnLateral Image: vertical distance between Prom pts and Lat ImageHorizontal Line C Lateral Promontory to Pub 4.412 N/A as no lat ImageSym image taken Hypotenuse but 4.412 remains the same D Lateral Anglebetween 36.094 deg To be Image Tilt Hypotenuse and line calculated Angleparallel to floor E Horizontal Pre-op line parallel to Not N/A Line thefloor or OR table important as no rotation Tilt Angle Relative change inpelvic tilt from the pre-op angle D to the intra-op angle DFrom FIGS. 11A and 11B: Sin angle D=3.179/4.412Angle=46.098 deg (intra-op angle D)Tilt angle=angle of intra-op image minus angle of standing imageTilt angle=46.098−36.094Tilt angle ˜10 degreesFIGS. 11C and 11D show what angles the navigation would set theimpaction at.Inclination=45 deg (remains unchanged)Version=20 deg anteversion minus 10 deg positive tilt=10 deg as shown

Example 4

The cue orientation pelvic orientation in this example is 45 DEGINCLINATION, 20° ANTEVERSION, and the intra-operative pelvic orientationis 0° TILT, 8° ROTATION (to be confirmed below) and 0° OBLIQUITY. FIGS.12 and 12A show an inter-operative top view (FIG. 12) and front view(FIG. 12A) of what a pelvis at 8 deg of Rotation looks like. FIG. 12shows standing x-ray plane 37 and rotational plane 140. Calculations fordetermining amount of rotation: Previously (similar to FIGS. 11 and 11C)taken pre-operative images are shown in FIGS. 12B and 12C. FIGS. 12D and12E are A/P Intra-operative images which show the pelvis may haverotated. This is to be verified. The following table 2 refers to thedimensions in FIGS. 12B to 12E.

TABLE 2 Name Feature length/ Letter Given angle Pre-op Intra-op APromontory Between Promontory 4.173 4.133 Line points B Normal On A/PImage: (90 2.599 2.599 Line deg) between Prom Line and Pub Sym. OnLateral Image: vertical distance between Prom pts and Lat ImageHorizontal Line C Lateral Promontory to Pub 4.412 N/A as no lat ImageSym image taken Hypotenuse but remains the same D Lateral Angle between36.094 deg N/A as no lat Image Tilt Hypotenuse and line image takenAngle parallel to floor but remains the same E Horizontal Pre-op lineparallel to Not To be Line the floor or OR table important calculated FMidpoint Line between Prom Not Not Line Line Midpoint and importantimportant Pub Sym G Rotational Distance between 0 0.496 Offset NormalLine and Distance Midpoint Line on Promontory Line H Rotational Angle ofPelvic 0 To be Angle Rotation of Intra-op calculated relative to Pre-opRotational Angle

Referring to FIG. 12E to find the Rotation Angle (H), first find lengthE.B ² +E ² =C ²E ² =C ² −B ²E ²=(4.412)²−(2.599)²E=3.565

The Lateral Image Horizontal Line dimension E found above, 3.565″, isnow used to help calculate the amount of intra-operative pelvicrotation. The Rotational Offset Distance (0.496″), FIG. 12D, was foundon the intra-op digital image device. Using these two numbers, theRotational Angle can be found.Sin H=0.496/3.565Rotational Angle H=7.997 degThe pelvis has rotated nominally 8 degrees

Note:

A less optimal way of determining the degree of rotation would be tocompare the pre-op Promontory Line distance (4.173) to the intra-opdistance (4.133). The 4.133 distance is a projection of the 4.173distance at the rotation angle.

Cos rotation angle=4.133/4.173

Rotation angle=7.939 degrees

FIG. 12F shows what 8 degrees of rotation looks like from a side viewwith sanding x-ray plane 37 and rotation plane 137.

Calculations for finding the impactor angles to be used by Navigationare shown in FIGS. 12G to 12J.

Step 1: Project the impactor angle position (45/20) onto the plane ofangle change. In this case it is the Rotation Plane shown in FIG. 12G.

${{TAN}\mspace{14mu} 45{^\circ}} = \frac{h}{R}$${{SIN}\mspace{14mu} 45{^\circ}} = \frac{h}{L}$${{COS}\mspace{14mu} 45{^\circ}} = \frac{R}{L}$${{SIN}\mspace{14mu} 20{^\circ}} = {{\frac{B}{R}\mspace{31mu} F} = {{SIN}\mspace{14mu} 20{^\circ}\mspace{14mu} R}}$F = (SIN  20^(∘))  (COS  45^(∘)) L ${{TAN}\;\alpha} = \frac{h}{F}$${{TAN}\;\alpha} = \frac{\sin\mspace{14mu} 45{^\circ}\mspace{14mu} L}{\left( {\sin\mspace{14mu} 20{^\circ}} \right)\mspace{11mu}\left( {\cos\mspace{14mu} 45{^\circ}} \right)L}$α = 71.118^(∘)

Step 2: Rotate 8° as shown in FIG. 12H (71.118-8°).

${\cos\mspace{14mu} 71.118{^\circ}} = \frac{F}{L^{R}}$${\cos\mspace{14mu} 63.118{^\circ}} = \frac{\left( {F + f} \right)}{L^{R}}$$\frac{F}{\cos\mspace{14mu} 71.118{^\circ}} = \frac{\left( {F + f} \right)}{\cos\mspace{14mu} 63.118{^\circ}}$$\frac{F}{.3236} = {\frac{F}{.4521} + \frac{f}{.4521}}$F = .7157F + .7157 f .2843F = .7157 f f = .3973 F

Step 3: As shown in FIG. 12I.

From Before: F=(cos 70°)(cos 45°)L

f = .3973 FF + f = (cos   70^(∘)) (cos   45^(∘)) L + .3973  (cos   70^(∘)) (cos   45^(∘)) LF + f = .3378 L ${{TAN}\mspace{14mu} 70{^\circ}} = \frac{D^{R}}{F}$${{TAN}\;\omega} = \frac{D^{R}}{F + f}$${{TAN}\;\omega} = \frac{{TAN}\mspace{14mu} 70{^\circ}\mspace{14mu} F}{{.3378}\; L}$${{TAN}\;\omega} = \frac{\left( {{TAN}\mspace{14mu} 70{^\circ}} \right)\;\left( {{COS}\mspace{14mu} 70{^\circ}} \right){L\left( {{COS}\mspace{14mu} 45{^\circ}} \right)}L}{{.3378}\; L}$TAN ω = 1.9670 ω = 63.052^(∘) = 90^(∘) − 63.052^(∘) = 26.947^(∘)

Step 4: Find cup impactor inclination angle as shown in FIG. 12J.

${{TAN}\mspace{14mu} 63.118{^\circ}} = \frac{h^{R}}{\left( {F + f} \right)}$From  Before:  F + f = .3378 L ${{SIN}\;\gamma} = \frac{h^{R}}{L}$${{SIN}\;\gamma} = \frac{\left( {{TAN}\mspace{14mu} 63.118{^\circ}} \right)\;({.3378})\; L}{L}$SIN γ = .6663 γ = 41.786^(∘)

The following angular values are used for the navigation system toeffectively impact a cup at a desired standing position of 45°/20°(inclination/anteversion) and are shown in FIGS. 12K and 12L. FIG. 12Lshows standing plane 37 and rotated plane 140.

Navigation version angle=26.947 deg

Navigation inclination angle=41.786 deg

Example 5

Here the cup impactor orientation is 45° INCLINATION, 20° ANTEVERSION,AND THE PELVIC ORIENTATION IS 0° TILT, 0° ROTATION, and 10° OBLIQUITY(to be confirmed below). FIGS. 13 and 13A show a top view and front viewof what a pelvis at 10 deg of Obliquity looks like. To find obliquitychanges, two points are identified on the intra-op pelvis (refer to FIG.9) to determine the angle of obliquity. The pelvis obliquity has changedby 10 degrees from the perfect position of 90 degrees.

Calculations for Finding the Impactor Angles to be Used by Navigation

Step 1: As shown in FIG. 13B, project pre angle change impactorinclination angle onto plane of angle change. In this case it is theStanding Image Plane 37 shown in FIG. 13. Calculation angles are shownin plane of standing x-ray in FIG. 13C.

Referring to FIG. 13C, project onto plane 37 (standing x-ray) that thechange in angle will take place.

${{COS}\mspace{14mu} 45{^\circ}} = {{\frac{R}{L}\mspace{31mu} R} = {{COS}\mspace{14mu} 45{^\circ}\mspace{14mu} L}}$${{COS}\mspace{14mu} 20{^\circ}} = {{\frac{A}{R}\mspace{31mu} A} = {\left( {{COS}\mspace{14mu} 20{^\circ}} \right)\;\left( {{COS}\mspace{14mu} 45{^\circ}} \right)\; L}}$${{SIN}\mspace{14mu} 45{^\circ}} = {{\frac{H}{L}\mspace{31mu} H} = {{SIN}\mspace{14mu} 45{^\circ}\mspace{14mu} L}}$${{TAN}\;\gamma} = {\frac{H}{A} = \frac{{SIN}\mspace{14mu} 45{^\circ}}{\left( {{COS}\mspace{14mu} 20{^\circ}} \right)\mspace{11mu}\left( {{COS}\mspace{14mu} 45{^\circ}\mspace{14mu} L} \right)}}$γ = 46.7808^(∘)

Step 2: Rotate 10 deg of Obliquity in plane of rotation (Standing ImagePlane).

Step 3: Calculate impactor version angle as shown in FIG. 13D.

$\begin{matrix}{{{{COS}\mspace{14mu} 46.7808{^\circ}} = {{\frac{A}{L^{1}}\mspace{31mu} L^{1}} = \frac{A}{{COS}\mspace{14mu} 46.7808{^\circ}}}}{{{COS}\mspace{14mu} 36.7808{^\circ}} = {{\frac{\left( {A + a} \right)}{L^{1}}\mspace{31mu} L^{1}} = \frac{\left( {A + a} \right)}{{COS}\mspace{14mu} 36.7808{^\circ}}}}{\frac{A}{.6848} = {\frac{A}{.8009} + \frac{a}{.8009}}}{A = {{{.8550}\; A} + {{.8550}\; a}}}{{{.1450}\; A} = {{{.8550}\;{a.a}} = {{.1695}\; A}}}} & \;\end{matrix}$From Before: a=(COS20°)(COS 45°)L

a = .1126 L so:  A = .6644L A + a = .7771 L Solve  for  σ${{Tan}\;\sigma} = \frac{d}{{.7771}\; L}$${{Tan}\mspace{14mu} 20{^\circ}} = \frac{d}{{.6644}\; L}$ d = .2418  L${{Tan}\;\sigma} = {{\frac{{.2418}\; L}{{.7771}\; L}\mspace{31mu}\sigma} = {17.283{^\circ}}}$

The new position of the impactor handle is 17.286 degrees off thereference. This is one of the input angles needed for navigation and isshown in FIG. 13E.

Now calculate the inclination angle of the impactor as shown in FIG.13F.

${{TAN}\mspace{14mu} 36.7808{^\circ}} = \frac{H}{\left( {A + a} \right)}$From  Before:  (A + a) = .7771 L ${{SIN}\;\delta} = \frac{H}{L}$${{SIN}\;\delta} = \frac{\left. {\left( {{TAN}\mspace{14mu} 36.7808{^\circ}} \right)\;{.7771}\; L} \right)}{L}$δ = 35.5166^(∘)  shown  in  FIG.  13G.

The following angular values are used for the navigation system toeffectively impact a cup at 45/20. Navigation version angle=17.283 deg;Navigation inclination angle=35.520 deg.

Example 6

Here the cup impactor orientation is 45 DEG INCLINATION, 20°ANTEVERSION, AND THE PELVIC ORIENTATION IS 0° TILT, 8° ROTATION (to beconfirmed below) and 10° OBLIQUITY (to be confirmed below). Calculationsfor determining amount of Obliquity and Rotation: Use the method inExample 4 to calculate the amount of Rotation, and use the method inExample 5 to calculate the amount of Obliquity. Calculations for findingthe impactor angles to be used by Navigation:

Step 1:

Use the method in Example 5 to find the following angles for the cupimpactor for 10 deg Obliquity:

Cup impactor version=17.283 deg

Cup impactor inclination=35.516 deg

Step 2:

Now project these onto the plane for rotation, rotate 8 deg, and projectback to plane that impactor is on (See FIG. 14).

FIG. 14 shows the cup impactor position prior to rotating 8 degrees

${{COS}\mspace{14mu} 35.516} = {{\frac{A}{L}\mspace{31mu} A} = {\left( {{COS}\mspace{14mu} 35.516} \right)L}}$${{SIN}\mspace{14mu} 35.516} = {{\frac{h}{L}\mspace{31mu} h} = {\left( {{SIN}\mspace{14mu} 35.516} \right)L}}$${{COS}\left( {{90{^\circ}} - {17.283{^\circ}}} \right)} = \frac{B}{A}$(COS  72.717) (COS  35.516)  L = B .2418 L = B${{TAN}\;\omega} = {\frac{h}{B} = \frac{\left( {{SIN}\mspace{14mu} 35.516} \right)\; L}{\left( {{COS}\mspace{14mu} 72.717} \right)\mspace{11mu}\left( {{COS}\mspace{14mu} 35.516} \right)\; L}}$ω = 67.400^(∘)

Now rotate 8 degrees as shown in FIG. 14Aσ=ω−8°σ=67.400−8°σ=59.400°

Now project back to plane of impactor as shown in FIGS. 14A, 14B and14C.

${{TAN}\mspace{14mu} 72.717} = \frac{m}{B}$${{TAN}\;\delta} = \frac{m}{\left( {B + b} \right)}$TAN (72.717)  B = TAN δ(B + b)${{COS}\mspace{14mu} 67.400} = {{\frac{B}{L^{1}}\mspace{31mu} L^{1}} = \frac{B}{{COS}\mspace{14mu} 67.400}}$${{COS}\mspace{14mu} 59.400} = {{\frac{B + b}{L^{1}}\mspace{25mu} L^{1}} = \frac{\left( {B + b} \right)}{{COS}\mspace{14mu} 59.400}}$$\frac{B}{{COS}\mspace{14mu} 67.400} = \frac{\left( {B + b} \right)}{{COS}\mspace{14mu} 59.400}$$\frac{B}{.3843} = {\frac{B}{.5090} + \frac{b}{.5090}}$B = .7549 + .7549b .2451B = .7549b b = .3246B${{TAN}\;\delta} = \frac{m}{\left( {B + b} \right)}$${{TAN}\mspace{14mu} 72.717} = \frac{m}{B}$ TAN(72.717)B = TAN δ(B + b)TAN(72.717)B = TAN δ(B + .3246 B) 3.2139 B = TAN δ(1.3246 B)2.4263 = TAN δ δ = 67.601^(∘)Navigated  impactor  version  90^(∘) − 64.601^(∘) = 22.399^(∘)

Find impactor inclination (shown in FIG. 14D).

${{TAN}\mspace{14mu} 59.400} = \frac{h^{1}}{\left( {B + b} \right)}$${{SIN}\;\alpha} = \frac{{TAN}\mspace{14mu} 59.400\;\left( {B + b} \right)}{L}$From  Before:  .2418 L = B  and  b = .3246 B b = .3216 (.2418) Lb = 0.785 L B + b = .2418 L + .0785 L = .3203 L${{SIN}\;\alpha} = \frac{{TAN}\mspace{14mu} 59.400\;({.323})\; L}{L}$α = 32.798^(∘)

The following angular values are used for the navigation system toeffectively impact a cup at 45/20. Navigation version angle=22.399 deg(FIG. 14C) Navigation inclination angle=32.798 deg (FIG. 14E)

Example 7

Here the cup impactor orientation is 45° INCLINATION, 20° ANTEVERSION,AND THE PELVIC ORIENTATION IS 10° TILT (to be confirmed below), 8°ROTATION (to be confirmed below) and 10° OBLIQUITY (to be confirmedbelow).

Calculations for determining amount of Obliquity and Rotation:

Use the method in Example 3 to calculate the amount of Tilt

Use the method in Example 4 to calculate the amount of Rotation

Use the method in Example 5 to calculate the amount of Obliquity

Calculations for Finding the Impactor Angles to be Used by Navigation:

Step 1:

Use the methods in Example 6 to find the impactor angles to be used forNavigation after applying 8 deg of Rotation and 10 deg of Obliquity.

Cup impactor version=22.399 deg

Cup impactor inclination=32.798 deg

Step 2:

Apply 10 deg of Tilt.

FIG. 15 shows the three basic x, y and z directions that angle changescan take place: Tilt, Obliquity, and Rotation. The three directions arealong the three basic vector directions of a coordinate system. InExample 6, Rotation and Obliquity were applied 90 degrees to each other.Following this approach, Tilt would be rotated around the third vector Y(perpendicular to the page) of the coordinate system. In FIG. 15, Tiltchanges would take place in the Central Plane 39 by rotating on the axisperpendicular (normal) to the Central Plane. The practical issue withthis is that the pelvis would be lifting off the OR table in doing this.FIG. 15A illustrates the extreme example of the pelvis with the sameRotation and Obliquity as FIG. 15, but with 180 deg of Tilt applied.

The pelvis is no longer laying on the operating room table with the legsresting along the plane of the table. In this position, the portion ofthe legs near the pelvis would be lifted off the table. This is not arealistic situation as the patient, no matter what the pelvic tilt, islaying flat on the table. Although this example is extreme, itdemonstrates that any pelvic tilt angle applied to the coordinate systemwould lift the legs up off the table. Calculations could be performed toproject the cup inclination and version angles found in Example 6 alongthe Central Plane 39, rotate the Tilt amount in this plane, andreproject as per the above examples. However, a more practical methodwould be to perform the calculations as per Example 6, and simply rotatethese results by the Tilt angle amount found as per Example 3.

Method to apply 10 deg of Tilt:

Step 1:

Find the amount of Tilt as per Example 3.

Step 2:

Perform calculations as per Example 6 for Rotation and Obliquity.Navigation angles found in Example 6 are shown in FIGS. 15B and 15C.

To apply 10 degrees of positive Tilt, simply subtract 10 degrees from22.402 deg to yield 12.402 degrees. The cup impactor inclination angleof 32.798 deg remains the same.

This example uses the apparent obliquity change when looking across thereference from the front of the OR table. In reality, the pelvis hasobliquely changed in the direction of the pelvic tilt. In this example,the obliquity would be 10 degrees off the front of table plane. Thecalculations below show what the actual obliquity would be (see FIG.15D).

${{TAN}\mspace{14mu} 10{^\circ}} = \frac{d}{h}$${{COS}\mspace{14mu} 10{^\circ}} = \frac{d}{L}$${{TAN}\;\delta} = \frac{L}{h}$${{TAN}\;\delta} = \frac{{TAN}{~~~}10{^\circ}}{{COS}\mspace{14mu} 10{^\circ}}$δ = 10.15^(∘)

The plane defined by the front of the table would be a plane thru d andh of FIG. 15D. The plane defined by the tilt plane in the direction ofthe standing x-ray image plane would be defined by L and h. The actualobliquity would be 10.15 degrees not 10 degrees. However, the differenceof 0.15 degrees is inconsequential in practice for cup positioning inhip surgery and that using 10 degrees for the calculations would beacceptable. Either method could be used.

The pre-operative image may show a leg shortening that needs correctionas shown in FIG. 16. Note that the pelvis is in the pre-operative x-rayshown in FIG. 16 is not parallel to the floor (the line joining points30 and 32 is not parallel). A line through points 30 and 32 is angled at5° from horizontal. The surgeon may want to correct for this. If a checkfor obliquity is taken in this image, it would show that the pelvis is 5degrees off. The method of measurements set forth above allows forcorrecting this. To correct for the 5 degrees, a measurement forobliquity as shown in FIG. 20 would be taken. But suppose the surgeonwants to keep the 5 degrees of obliquity, then the extra 5 degrees isadded/subtracted from the intra-operative obliquity measurement and usedto calculate the impactor inclination angle.

It is assumed that the intra-operative image is taken perpendicular(normal) to reference bar 40. Normally, this is a good assumption, butin practice, it may be a few degrees off from being perpendicular. Thiscould be accounted for in two ways:

The two or more radiopaque points in the reference bar could be atprecise distance apart from each other. Any angular differences in theimage would result in a difference in measurement between the pointswhich can be calculated in the computer.

The preferred reference bar is radiolucent, and has two radiopaguespheres (44, 45) embedded in reference bar 40 3 inches apart. Anyangular differences in the image would result in a difference inmeasurement between spheres 44 and 45. An image that is takenperpendicular to bar 40 would show a 3 inch measurement between theradiopaque spheres. However, an image at a 10 degree angle to the barwould show a distance of 2.954 inches long. So in practice, an imagewould be taken and the actual distance on the image compared against theknown distance of 3 inches. It would be discovered that the image isbeing taken at an angle to the reference at that time. The x-raydirection could then be changed to account for it, or the calculated 10degree angle could be used as a modifier to the follow-up dimensions tobe used for obliquity, tilt, and rotation.

If for some reason it is suspected that the x-ray emitter is also takenat an angle to the floor, as in pointing more to the floor or away,another option would be to include a third radiopaque marker in thereference bar that could be used for angular corrections.

Using the above methodology to determine the pelvis locationintra-operatively can have benefits beyond cup placement. Another usewould be for drilling along a certain direction in times where it isdesirable to place a screw in the area having the most bone. An exampleof this would be in a severe revision situation whereas bone erosion cancomprise desirable areas to have fixation.

Alternately, a navigation tracker could be placed on the x-ray emitteritself and used to make automatic corrections. If for some reason it issuspected that the x-ray emitter is also taken at an angle to the floor,as in pointing more to the floor or away, another option would be toinclude a third radiopaque marker in the reference that could be usedfor angular corrections. The navigation tracker could be used for thisas well.

This invention describes the benefits of taking a pre-operative standingimage vs. a pre-operative supine image. A standing image takes intoaccount the normal pelvic position for each individual patient asopposed to a laying down/supine image which can alter the pelvisposition similar to laying down on the operating table.

However, the invention does not exclude supine images, bothpre-operative and intra-operative. For example, for the direct anteriorsurgical approach, the patient is supine on the table. It could beargued that the pelvis may have similar angular changes for the supinepre-operative x-ray image to the intra-operative supine position on thetable, and therefore, in a way, recreating a natural standing pelvicposition due to the similar angular changes.

At a minimum, the two A/P promontory points and the public symphysispoint needs to be taken. If only these three points are taken, the linebetween the promontory points could help dictate the obliquity angle,and an assumption could be made that the x-ray emitter is parallel tothe operating table and floor, and therefore, any line parallel to thefloor on the image could be the reference. This also assumes that theimage detector is parallel to the operating table and/or floor.

A common operating room table can be adjusted in two ways: trendelenburg(about the long axis of the table) and lateral tilt (about the shortaxis of the table). It is conceivable that the table could be adjustedto account for pelvic obliquity and rotation prior to an intro-operativeimage to account for any angular changes. This would be an attempt toadjust the table in order to place the pelvis at the “perfect” position90° to the floor as described above, and therefore a surgeon couldsimply use the impactor at the 45°/20° position to the floor. There aretwo major issues with this that this invention addresses. First, thereare only two adjustments with the table, not three. There is not anadjustment for tilt and therefore the surgeon would need to somehowadjust for this. Second, multiple intra-operative images would have tobe taken in order to get the exact position needed for the pelvis. Forinstance, the table would have to be tilted to remove anyintra-operative pelvic rotation. An image would be taken, and a guess asto how much the table would be adjusted to remove rotation. Anotherimage taken, and further adjustment until the pubic symphysis isdirectly positioned over the sacrum. This would be a visual positioning,as well as adjusting for obliquity with trendelenburg table adjustments.

An alternative method is shown in FIGS. 17-24. This method requires onlya single x-ray of the patient and works best when used in an anteriorapproach for acetabular prosthetic joint replacement. In an anteriorapproach the patient is supine i.e., laying on his or her back.Referring to FIGS. 17 to 19 there is shown schematically a standinglateral image of pelvis 10 showing an anterior pelvic plane 200, whichplane is defined by three points; namely, the pubic synthesis 208, theright anterior superior iliac spine 204, and the left anterior superioriliac spine 206, which can be seen on the schematic of FIG. 19. In FIG.17a coronal plane 202 is located perpendicular to the floor on which thepatient is standing and the natural pelvic tilt angle (here shown as12°) between the coronal plane and the anterior pelvic plane (APP) canbe easily measured or calculated. Natural pelvic tilt (the angle betweenthe APP and coronal plane can vary from 20° to 20°. Typically the x-rayof pelvis 10 is a digital x-ray allowing software to calculate anyrequired planes or distances.

When performing the operation, the patient with pelvis 10 is placed in asupine i.e. laying on the patients back on the operating table 46. Notethat pelvis 10 can exhibit some tilt, obliquity in rotation after beingplaced on the table 46. As shown in FIG. 19, the right anterior superioriliac spine 204, the left anterior superior iliac spine 206, and thepubic synthesis 208 shown on pelvis 10 can be accessed in the supine.

A tracker 210 may be brought into contact with each of the points 204,206, and 208 to locate them in the operating room orientation trackingsystem. Such a system may be a typical optical tracking system locatedin the operating theatre. After locating points 204, 206 and 208, thetracker 210 then may be fixedly mounted on the pelvis to track anychanges in position which may occur during the implantation of anacetabular cup. As indicated above, the three points 204, 206, and 208are used to determine the anterior pelvic plane. Since the pelvic tiltangled between the anterior pelvic plane 212 and the coronal plane 214is known from the standing x-ray, the orientations of the two planes canbe reproduced.

Referring to FIG. 22, a sagittal plane 216 is drawn through the midpointbetween the right and the left anterior superior iliac spines 204, 206with the sagittal plane 216 being perpendicular to coronal plane 214.Since at this point in the method the locations of the sagittal plane216 and the coronal plane 214 are known, a predetermined abduction inversion (anteversion) angles can be measured with respect to the centerof the acetabulum 220. Thus, FIGS. 23 and 24 show an arbitrary exampleof 40° in abduction in the coronal plane of an acetabular insertioninstrument, such as an impactor or a reamer, which is in all respects issimilar to that described above with respect to the other embodiments.FIG. 24 shows a version angle of 20° from the coronal plane in thesagittal plane with the same instrument.

The advantage of this alternate method for use, preferably in the supineposition, is that no interoperative x-rays are required. Thus, only asingle, one, individual, digital standing x-ray of a patient need betaken when using the direct anterior or anterolateral approach inreplacing an acetabular cup (both approaches are performed with thepatient in the supine position, i.e., laying on his or her back on theoperating table). While this alternate process is best used with thepatient in the supine position, it may also be used with other operativeapproaches.

FIG. 25 shows a typical operating room navigation or orientation systemgenerally denoted as 300. The relative position of the patient's bones,such as the patient's femur 99 and the patient's pelvis 10′, can bedetermined and tracked by attaching reference bodies or trackers 301,310, which include reflective markers 302, 312. Reference bodies ortrackers 301, 310 can be attached to bones or tools by using pins orscrews (304, 314) or various quick release mechanisms. In the embodimentof FIGS. 17-24 only tracker 310 is attached to the pelvis. Tracker 301is not required. Tracker 301 can be used to locate points 204, 206 and208 as discussed above with tracker 310 attached to pelvis 10′. Thetracked objects and their relative positions can be displayed on ascreen 332 that is connected to the computer system 305. In anembodiment, the display 332 is a touch screen which can also be used fordata entry. The position measurement and alignment system 306 includes apositioner 50 used to align the acetabular cup insertion positioninginstrument or an acetabular reamer. The positioner 50 has the referencebody or position tracker 52 thereon and an acetabular reamer or cupholder 308. The user interface screen or monitor 332 is used to displaythe position of the acetabular cup holder or reamer 50 with regard tostored patient digital x-ray and other data. The reference body 52 istracked in space by a camera system 349 which includes light-emittingspheres 350. Thus positioner 50 can be tracked during the surgery in aknown manner to set the desired angles with respect to pelvis 10.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

The invention claimed is:
 1. A method for aligning an acetabular cupinsertion instrument using an x-ray system and an operating roomnavigation or orientation tracking system, the method comprising: takinga single lateral pre-operative x-ray image of a standing patient'spelvis with the x-ray system, the single lateral pre-operative x-rayimage being in a plane generally aligned with a sagittal plane of thepatient perpendicular to a surface on which the patient is standing;locating an anterior pelvic plane (APP) using the single lateralpre-operative x-ray image, the APP defined by a first point on a pubicsymphysis, a second point on a left anterior superior iliac spine and athird point on a right anterior superior iliac spine; determining, basedon the single lateral pre-operative x-ray image, a natural pelvic tiltangle by calculating an angle between the APP and a coronal planeperpendicular to the surface on which the patient is standing;calculating, using the single lateral pre-operative x-ray image,distances between the first point and the second point, the second pointand the third point, and the first point and the third point; placingthe patient on a surface of an operating room table; placing a firstposition tracking device on the patient's pelvis to intra-operativelytrack movement of the pelvis during surgery, wherein the first positiontracking device is used to intra-operatively locate the first, secondand third points when the patient is on the operating room table,thereafter using the operating room navigation or orientation trackingsystem to intra-operatively determine the APP defined by the first,second and third points; using the APP determined intra-operatively inconjunction with the natural pelvic tilt angle determined based on thesingle lateral pre-operative x-ray image to reproduce the coronal plane;and using the operating room navigation or orientation tracking systemto orient and align the acetabular cup insertion instrument having asecond position tracking device mounted thereon at a predeterminedanteversion angle with respect to the coronal plane.
 2. The method foraligning an acetabular cup insertion instrument as set forth in claim 1,further comprising defining the sagittal plane through a mid-pointbetween the intra-operatively located second and third points andperpendicular to the coronal plane.
 3. The method for aligning anacetabular cup insertion instrument as set forth in claim 2, furthercomprising orienting the cup insertion instrument at a predeterminedabduction angle with respect to the sagittal plane.
 4. The method foraligning an acetabular cup insertion instrument as set forth in claim 3,wherein the predetermined desired cup abduction and anteversion anglesare about 30 to 50 degrees and 10 to 30 degrees respectively.
 5. Themethod for aligning an acetabular cup insertion instrument as set forthin claim 1, wherein the orientation of the cup insertion instruments isdirected by a computer using digital image analysis software receivinginput from the single lateral pre-operative x-ray image and the secondposition tracking device.
 6. The method for aligning an acetabular cupinsertion instrument as set forth in claim 1, wherein the single lateralpre-operative x-ray image is a digital x-ray image.